MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ADERMA STANDARD HEEL; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801097

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

It was reported that the patient has used the dressings and each time within a few hours they are crumbling.The edge of the pads that should support the side of the heel are breaking away.The product is deteriorating and breaking up into small pieces, leaving residues on the wound after being used.

Event Description

It was reported that the patient has used the dressing and within a few hours it is crumbling.The edge of the pad that should support the side of the heel are breaking away.The product is deteriorating and breaking up into small pieces, leaving residues on the wound after being used.

Manufacturer Narrative

We have now concluded our investigation into this complaint.A review of the manufacturing batch record found there were no processing issues during the production of this lot.Complaint samples were contaminated and disposed of so not available for assessment.However, the retained samples were examined and there was no evidence of deterioration.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The investigation found that the product was manufactured in accordance with procedures and within validated conditions and the finished product conformed to specification.There were no other issues or deviations during the manufacturing process that could have caused or contributed to the experienced by the end user.There were also no change controls associated with this lot and all the raw materials were compliant with the specification.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ADERMA STANDARD HEEL
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8319140
• MDR Text Key: 135510250
• Report Number: 8043484-2019-00095
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801097
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1